BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5616051 · Received April 28, 2016

    Report

    Report Number
    2951250-2016-00439
    Event Type
    Injury
    Date Received
    April 28, 2016
    Report Date
    January 23, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY SAFETY EVALUATION RECEIVED ON 17-JUN-2016: (B)(4). IN THIS CASE NO PRODUCT WAS RETURNED. FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 20-JUN-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: BACK PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS NON MEDICALLY-CONFIRMED, SPONTANEOUS CASE REPORT WAS RECEIVED VIA REGULATORY AUTHORITY AND REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD LUMBAR PAIN AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. THIS EVENT IS LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, BACK PAIN MAY OCCUR. IN THIS PARTICULAR CASE, CONSUMER RELATED THE EVENT TO ESSURE AND NO ALTERNATIVE EXPLANATION WAS PROVIDED. THEREFORE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. IN ADDITION, THE EVENTS JOINT PAIN AND LOSS OF HAIR WERE REPORTED AND CONSIDERED UNRELATED TO ESSURE DUE TO THEIR NATURE. ALTHOUGH NO DEATH OR SERIOUS INJURY WAS MENTIONED IN THIS CASE; IT WAS REGARDED AS AN INCIDENT IN LINE WITH HEALTH AUTHORITY'S ASSESSMENT. A PRODUCT TECHNICAL INVESTIGATION CANNOT BE PERFORMED AS NO BATCH NUMBER OR SAMPLE PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A (B)(6) FEMALE CONSUMER VIA REGULATORY AUTHORITY (CASE# PS/CV/SHC/32912) IN (B)(6) ON 04-APR-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON AN UNSPECIFIED DATE. SIX MONTHS AFTER INSERTION THE CONSUMER EXPERIENCED LUMBAR PAIN, JOIN PAIN, AND LOSS OF HAIR. SHE REPORTED HER CURRENT HEALTH STATE AS WORSENING AND STATED SHE USED TREATMENT FOR THE RELIEF OF THE ADVERSE REACTION (NOT SPECIFIED). ALL THE EVENTS WERE CONSIDERED AS RELATED BY CONSUMER. INTERNAL CORRECTION ON 05-APR-2016 BASED ON INFORMATION RECEIVED ON 04-APR-2016: THIS CASE WAS UPGRADED TO INCIDENT (IT WAS CONSIDERED INCIDENT BY REGULATORY AUTHORITY). COMPANY CAUSALITY COMMENT: THIS NON MEDICALLY-CONFIRMED, SPONTANEOUS CASE REPORT WAS RECEIVED VIA REGULATORY AUTHORITY AND REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD LUMBAR PAIN AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. THIS EVENT IS LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, BACK PAIN MAY OCCUR. IN THIS PARTICULAR CASE, CONSUMER RELATED THE EVENT TO ESSURE AND NO ALTERNATIVE EXPLANATION WAS PROVIDED. THEREFORE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. IN ADDITION, THE EVENTS JOINT PAIN AND LOSS OF HAIR WERE REPORTED AND CONSIDERED UNRELATED TO ESSURE DUE TO THEIR NATURE. ALTHOUGH NO DEATH OR SERIOUS INJURY WAS MENTIONED IN THIS CASE; IT WAS REGARDED AS AN INCIDENT IN LINE WITH HEALTH AUTHORITY'S ASSESSMENT. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270108 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R